广州招聘

【主要职责-Key Responsibility】
QA专员主要协助和支持各位专家及顾问开展GMP相关的项目，这里，您可以全面接触各类项目，并逐步积累工作和项目经验，为进一步的职业发展夯实基础。
Assist Experts for executing GMP relevant projects. Here, you will accumulate the working and project experience by participating different projects, which is helpful for consolidating the foundation of career development.

【职位描述-Job Description】
1. 收集、更新制药及其他生命科学行业相关的法规要求；
2. 根据最新的法规要求和实际操作，支持编写GMP文件，包括质量管理、实验室管理、生产管理、物料及仓储管理、设施及设备管理等；
3. 根据项目需求，协助翻译相关GMP文件；
4. 支持专家参与各类审计项目，如无菌、制剂、原料药、包材及辅料审计；
4. 协助准备培训材料，协助跟踪项目进展，配合客户完成工作；
5. 其它安排的项目工作。
Ⅰ Collect and update the regulatory requirements related to pharmaceutical and other Life Sciences industries.
II Support preparating GMP SOPs according to the latest regulatory requirements and actual practices, i.e. Quality Management, Lab Management, Manufacture Management.
III Assist in translation GMP documentation.
IV Support audit execution, including: sterilization, drug, API, package, etc.
V Assist in preparing training document and follow up the project procedure, reach client’s requirements.
Ⅵ Other duties as assigned.

【任职要求-Expectation】
1. 药学、制药工程、化学和生物科学等相关专业；
2. 具备药品质量和生产相关专业知识，熟悉海外和中国GMP等法规相关知识；
3. 至少四年制药工厂质量保证/管理部门工作经验；*必须
4. 有质量体系建立经验者优先考虑；
5. 良好英语阅读和书写能力。
Ⅰ Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.
II Pharmaceutical knowledge in quality or manufacturing of drugs. Familiar with overseas and Chinese GMP regulations is preferred.
III Minimum of 4 years plant QA experience in pharmaceutical industry. *kindly note that year of working experience is essential.
IV Experiences on quality system establishment is preferred.
V Good knowhow in English reading and writing.

加入德恩，预见更好的人生！Meet The Better You in gempex!

预见我们Foresee Us
德恩是一家独立的、全球化的服务供应商，专注于为生命科学行业提供GMP咨询与执行服务。公司总部位于德国曼海姆，并在瑞士锡瑟而恩和中国广州、苏州设有分支。
德恩总部gempex GmbH成立于2002年，公司的客户涵盖制药、化学、生物、化妆品和医疗器械等领域的领军企业。公司专注于提供GMP符合性、确认与验证、计算机验证和GMP生产相关的咨询和项目执行服务，服务范围从初始阶段的分析和概念筹划到最终实现。
gempex GmbH is an independent, international service provider specializing in consultancy and the implementation of GMP requirements in the life science industry. Headquartered in Mannheim, Germany, gempex also has sites in Sisseln, Switzerland and Guangzhou, China.
The company was founded in 2002.Customers include leading companies in the chemical and pharmaceutical industries, biotechnology, cosmetics and medical devices. Services focus on consultancy and project implementation for GMP compliance, commissioning & qualification, IT validation and GMP routines. The range of services extends from the initial analysis and concept development to their final realization.

预见机遇Foresee Your Career
我们欢迎充满激情、专业、着眼于客户、注重细节、并愿意为德恩以及客户创造价值的人才加入我们的团队：
We invite you to bring your passion, expertise and customer-oriented sense and explore career opportunities in your field of interest to your success at gempex.
What we are looking for:
-高级GMP 顾问 Sr. GMP Consultant
-GMP顾问 GMP Consultant
- GMP专家 GMP Expert
- GMP专员 GMP Specialist

预见未来的你Foresee Your Life@gempex
加入德恩，成为我们的一员。在这里，大家虽然个性不同，但拥有为实现目标而不懈努力的激情，系统培训与个性发展是您将在德恩的重要收获。我们竭诚为我们的员工提供富有竞争力的薪酬福利、绩效激励以及职业发展。我们为您提供：
五险一金 商业保险 11天带薪年假 年终奖金 年度体检 年度旅游 节日福利 员工活动 不定期下午茶 免费午餐
Join gempex, we are an inclusive highlighted by respect, collaboration, open and honest communication and diverse culture. We offer long-term adventure, daily reward, training and opportunity to carve out a unique and vibrant career.

联系我们Contact us:
企业网址Website：******
企业公众号 WeChat：gempexChina
招聘公众号 WeChat：gempex_China